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Nonsteroidal Anti-inflammatory Drug

OMT/NSAID for Low Back Pain

Phase 4
Recruiting
Led By Alexis Cates, DO
Research Sponsored by Albert Einstein Healthcare Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* All patients 18 years of age or older with the chief complaint of acute low back pain defined as symptom duration no longer than four weeks prior to ED presentation and having clinical findings of somatic dysfunction (muscle edema, erythema, bogginess, hypertonic muscles, asymmetry of tissue, pain with movement, severe/sharp tenderness).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 45 minutes
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
No Placebo-Only Group

Summary

This trial will investigate whether osteopathic manipulative treatment (OMT) is more effective than NSAIDs for treating acute low back pain in the emergency department.

Eligible Conditions
  • Low Back Pain
  • Lower Back Pain

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 45 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain score
Secondary study objectives
Patient Satisfaction
Physician Satisfaction

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: OMT/NSAIDActive Control2 Interventions
Ibuprofen, 800 mg, one time dose
Group II: NSAIDActive Control1 Intervention
Ibuprofen, 800 mg, one time dose
Group III: OMT aloneActive Control1 Intervention
low velocity osteopathic manipulative medicine

Find a Location

Who is running the clinical trial?

Albert Einstein Healthcare NetworkLead Sponsor
64 Previous Clinical Trials
868,535 Total Patients Enrolled
1 Trials studying Low Back Pain
Alexis Cates, DOPrincipal InvestigatorEinstein Healthcare Network
Joseph Herres, DOStudy DirectorEinstein Healthcare Network
1 Previous Clinical Trials
43 Total Patients Enrolled
~31 spots leftby Nov 2025
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